(67 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML technology.
No
The device is described as a disposable glove intended to prevent contamination between a patient and an examiner, not to treat or cure a disease or condition.
No
The document describes examination gloves, which are used to prevent contamination between patient and examiner. There is no mention of the device being used to identify or analyze a condition.
No
The device is described as physical gloves, which are hardware, not software. The summary focuses on physical properties and testing standards for gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 5250-06). It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, and descriptions of training/test sets, performance studies with metrics like AUC, sensitivity, specificity, etc. These are common elements in IVD device descriptions.
- Predicate Device: The predicate device is also a type of examination glove, reinforcing that this is a barrier device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2006 Third Edition 2010-08-01.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
Clinical studies:
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: در بہ (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | HEBEI LEADER PLASTIC CO., LTD | ||
|---|---|---|---|
| Submitter's address : | #77, ZHONGSHAN WEST RD. | ||
| SHIJIAZHUANG,050000 CHINA | |||
| Phone number : | (86) 311-67699886 | ||
| Fax number : | (86) 311-67699916 | ||
| Name of contact person: | Mr. WANG Fei | ||
| Date the summary was prepared: | Sep. 19th, 2012 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder free Vinyl Patient Examination Gloves, Colored
(Yellow) |
|-------------------------|-------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) is a. disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &
Description | Predicate Device | Medical Glove
Guidance
Manual(1661) | Subject Device | Result of
Comparison |
|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Company | SHIJIAZHUAN
G MANFUL
LIGHT
INDUSTRIAL
PRODUCTS
CO., LTD | | HEBEI LEADER
PLASTIC CO.,
LTD | -- |
| Product name | Powder free
Vinyl Patient
Examination
Gloves(White,
Yellow) | | Powder free Vinyl
Patient
Examination
Gloves, Colored
(Yellow) | -- |
| Intend for use | Powder free
Vinyl Patient
Examination
Gloves, Colored
(White, Yellow)
is a disposable
device intended
for medical
purposes that is
worn on the
examiner's hand
or finger to
prevent
contamination
between patient
and examiner. | Powder-Free
Examination
Gloves:
A powder-free
patient examination
glove is a disposable
device intended for
medical purposes
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | Powder free Vinyl
Patient
Examination
Gloves, Colored
(Yellow) is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | Substantially
equivalent |
| Device
Description and
Specifications | Meets ASTM
D5250 | If vinyl:
Do the vinyl
examination gloves
meet all the current
specifications listed
under ASTM
Specification D5250
or an equivalent
consensus standard? | Meets ASTM
D5250 | Substantially
equivalent |
| Compare all
materials used to
fabricate the
devices | PVC | If the glove is made
of a polymer or
other type of
material. identify the
material. | PVC | Substantially
equivalent |
| Dusting or
Donning Powder: | PU | If a donning
lubricant is used | PU | Substantially
equivalent |
| | | state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below | | |
| Dusting or
Donning Powder:
name | PU | Lubricant
Generic Name/
Lubricant
Brand Name | Surface Coating
Agent | Substantially
equivalent |
| Compare product
specifications | Meets ASTM
D5250 | We recommend you certify that your finished "powder-free" gloves meet the following:
ASTM D 5250 standard or an equivalent standard for vinyl | Meets ASTM
D5250 | Substantially
equivalent |
| Compare
performance data
supporting
substantial
equivalence | Meets
ASTM D5151
ASTM D5250
ASTM D6124 | At this time FDA recognizes the following standards:
Patient Examination Gloves(PVC)
ASTM D5151(Detection of Holes in Medical Gloves)
ASTM D6124(Residual Powder on Medical Gloves)
ASTM D5250(Poly(vinyl chloride) Gloves) | Meets
ASTM D5151
ASTM D5250
ASTM D6124 | Substantially
equivalent |
| Single Patient Use | Single Patient
Use | Single Patient Use | Single Patient Use | Substantially
equivalent |
| Biocompatibility | SKIN
IRRITATION
DERMAL and
SENSITIZATION
STUDIES
Meets ISO
10993-10 | SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES
ISO 10993-10 | SKIN
IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets
ISO 10993-10 | Substantially
equivalent |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder-Free
-Patient
Examination
Glove
-Single Use Only
- Manufactured
For: - Lot | Chapter 4 | -Powder-Free
-Patient
Examination Glove
-Single Use Only - Manufactured
For: - Lot | Substantially
equivalent |
2
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2006 Third Edition 2010-08-01.
3
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
4
Section 15
Substantial Equivalence Discussion
The Powder free Vinyl Patient Examination Gloves, Colored (Yellow) made by HEBEI LEADER PLASTIC CO., LTD, have the same intended use and technological characteristics as the Predicate devices, Powder free Vinyl Patient Examination Gloves(White, Yellow) made by SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156.
The Subject Device is substantially equivalent to the predicate devices with regard to technologies, in design and very similar construction, material, function, and application. More detail information on the Table 1.
Based on the information in following Table I, II & III , the Subject Device (Powder free Vinyl Patient Examination Gloves, Colored (Yellow)) has the same technological characteristics as the predicate device. The Powder free Vinyl Patient Examination Gloves, Colored (Yellow) made by HEBEI LEADER PLASTIC CO., LTD, are substantially equivalent to the predicate devices.
5
Image /page/5/Picture/0 description: The image shows a logo for the Department of Health and Human Services - USA. The logo includes a symbol with three curved lines, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The text is in a circular format.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 30, 2012
Hebei Leader Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, China 100083
Re: K122920
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 19, 2012 Received: November 1, 2012
Dear Mr. Xiaoan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Xiaoan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Heath's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Anthong Lo min
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
7
INDICATIONS FOR USE
Applicant: HEBEI LEADER PLASTIC CO., LTD
510(k) Number (if known): * 122920
Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Maria Cruz-ISher Cruz-Fisher Scorminaria Cruzen. Maria Cruzen. Maria Cruzena. Maria 1920200.00.11.1.
Data 113112 - Data 113.000 1130113011301130113011131114910 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K122420